UMIN-CTR Clinical Trial

Basic information
Public title	Effect of COVID-19 mRNA Vaccine on Semen Parameters
Acronym	Effect of COVID-19 mRNA Vaccine on Semen Parameters
Scientific Title	Effect of COVID-19 mRNA Vaccine on Semen Parameters
Scientific Title:Acronym	Effect of COVID-19 mRNA Vaccine on Semen Parameters
Region	Japan

Condition
Condition	Male infertility
Classification by specialty	Obsterics and gynecology Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assessment of the effect of COVID-19 mRNA Vaccine on semen parameters among 20 male volunteers.
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Semen Analysis Time Frame: 1)Before the first mRNA COVID-19 vaccine (2 times) 2)2 weeks after the first COVID-19 vaccine (2 times) 3) 2 weeks after the second COVID-19 vaccine (2 times) 4) 4 weeks after the second COVID-19 vaccine (2 times) * 2 days of abstinence period before semen collection
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	50 years-old >=
Gender	Male
Key inclusion criteria	1. Male Volunteers 2. Ages 20-50 3. Unvaccinated at the time of enrollment. Vaccinate with the first and second Pfizer's COVID-19 Vaccine from May to December 2021. 4. Able to supply semen samples 8 times in total as scheduled. 5. Submission of signed informed consent with ability and willingness.
Key exclusion criteria	1.Taking medications that would interfere with semen analysis parameters. 2.History of COVID-19 infection at the time of enrollment. 3.Not eligible to receive COVID-19 mRNA vaccination due to health factors.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tomomoto Middle name Last name Ishikawa
Organization	Reproduction Clinic Osaka
Division name	Reproduction Clinic Osaka
Zip code	530-0011
Address	15F, Grand Front Osaka Tower A, 4-20 Ofuka-cho, Kita-ku, Osaka 530-0011 Japan
TEL	06-6136-3344
Email	tishikawa@reposaka.jp

Public contact
Name of contact person	1st name Tomomoto Middle name Last name Ishikawa
Organization	Reproduction Clinic Osaka
Division name	Reproduction Clinic Osaka
Zip code	530-0011
Address	15F, Grand Front Osaka Tower A, 4-20 Ofuka-cho, Kita-ku, Osaka 530-0011 Japan
TEL	06-6136-3344
Homepage URL
Email	tishikawa@reposaka.jp

Sponsor
Institute	Reproduction Clinic Osaka
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Reproduction Clinic Osaka Research Ethics Committee
Address	15F, Grand Front Osaka Tower A, 4-20 Ofuka-cho, Kita-ku, Osaka 530-0011 Japan
Tel	06-6136-3401
Email	htakizawa@reposaka.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	リプロダクションクリニック大阪（大阪府）/ Reproduction Clinic Osaka (Osaka)

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 26 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2021 Year 04 Month 26 Day
Date of IRB	2021 Year 05 Month 15 Day
Anticipated trial start date	2021 Year 05 Month 15 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A prospective study comparing semen parameters among male volunteers aged 20-50, before and after receiving the first and second dose of Pfizer's COVID-19 vaccination. Currently, there is no medical and scientific information which evaluated semen parameters following the COVID-19 vaccination.

Management information
Registered date	2021 Year 05 Month 26 Day
Last modified on	2021 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050574